This is a compilation of the recent regulatory updates for Brazil. Every week, we post an update of what's new, which you can view here.
- July 25: The latest draft version of the Normative Instruction circulated on July 13 mirrors Brazilian Law: All supply chain stakeholders (manufacturers, importers, wholesalers, dispensers (with the exclusion of national healthcare systems and clinics/health offices) are expected, beginning on April 28, 2022, to report all transactions on serialized products. All in-scope products are required to be serialized by this date. Next meeting of the ANVISA directors (DICOL) meeting is on August 4.
- July 18: A new draft of the Normative Instruction was distributed to Brazilian pharmaceutical associations on July 13.
- The new draft version mirrors Brazilian Law: All supply chain stakeholders (manufacturers, importers, wholesalers, dispensers with the exclusion of national healthcare systems and clinics/health offices) are expected, on April 28, 2022, to report all transactions on serialized products.
- All in-scope products are required to be serialized by this date. Unlike previous versions of the NI, this draft does not contain any intermediate deadlines, nor mention of an “Implementation” phase, nor additional exceptions for stakeholders or product classes other than those originally exempted.
- The new draft requires manufacturers and importers to submit a Serialization Plan to ensure readiness by April 28, 2022. No deadline for submission was indicated.
- July 11: The Normative Instruction was not discussed at the July 7 ANVISA directors (DICOL) meeting. However, a new draft was released on July 13 and ANVISA has invited Sindusfarma and other industry groups to review prior to final approval. Next ordinary meeting is July 22.
- July 4: ANVISA remains in the process of finalizing the Normative Instruction, but there has been no additional information on the degree of change between the latest draft and the March 2021 draft. The Normative Instruction was not on the agenda of the July 8 meeting of ANVISA directors (DICOL).
- June 27: ANVISA remains in the process of finalizing the Normative Instruction, but there has been no additional information on the degree of change between the latest draft and the March 2021 draft. The next meeting of the ANVISA directors (DICOL) is July 8. Some topics on medical devices/UDI (unique device identification) systems were discussed at the June 22 meeting.
- June 20: The next scheduled meeting of the ANVISA Directors (DICOL) is June 22. The Normative Instruction is not on the agenda.
- June 13: The Normative Instruction was not discussed at the ANVISA Directors (DICOL) meeting on June 9. The next scheduled meeting is June 23.
- June 6: The Normative Instruction was not on the ANVISA Directorship (DICOL) agenda for its June 4 June 9 meetings. The next scheduled ordinary meeting is June 23. Most meeting topics are centered on vaccine approval and distribution issues.
- May 30: The Normative Instruction was not discussed at the DICOL Meeting on May 26. The next scheduled meeting is June 10.
- April 11: The Normative Instruction was not discussed at the April 7 meeting of ANVISA directors ( DICOL), nor is it on the agenda for April 14 due to the nation’s COVID crisis. The next meeting will be April 29.
- March 28: ANVISA’s DICOL meetings took place on March 24 and 25, but the draft Normative Instruction issued on March 12 was not discussed. The current draft of the Normative Instruction, despite clarifying some elements from the previous version, continues to generate discussion on its requirements for both reporting and serialization. Further meetings are scheduled on April 7, 15, and 29.
- January 31: The ANVISA directorate (DICOL) meeting on January 26 did not include traceability on its agenda due to the immediate need to address COVID-related topics. The next meeting will be on February 9.
- January 24: The agenda for the January 26 meeting of ANVISA directors (DICOL) did not contain topics on the SNCM or on traceability compliance. The next opportunity for discussion will be at the February 9 session.
- December 20: The latest draft of the Normative Instruction was not finalized at the December 15 ANVISA directors (DICOL) meeting, but there is speculation that companies will be required to begin “assisted implementation” (a form of reporting to SNCM) beginning in April, 2021. The previous draft requirement for companies to file an “Implementation Plan” by December 31, 2020 is not included in the latest draft of the Normative Instruction. The next DICOL meeting is scheduled for January 26, 2021.
- December 6: The latest draft of the Normative Instruction lists phased deadlines by product class starting in 2022. The next DICOL meeting on December 15 may provide further updates on approval of the regulation. The deadline for companies to register their Implementation Plans remains December 31, 2020.
- November 29: The ANVISA Directorate (DICOL) is scheduled to meet on December 1 and is expected to discuss the Normative Instruction draft.
- November 29: According to GS1 Brazil, first steps in architecture and technology have been made to address the horizontal integration requirement and will use the ANVISA reporting architecture as a starting point.
- November 22: The Normative Instruction was not on the DICOL (ANVISA Directorate) November 17 meeting agenda. The next meeting will be on December 1, when a new draft of the regulation may be approved or when proposed phased deadlines based on discussions between ANVISA and domestic pharmaceutical industry associations may be addressed.
- November 15: Minutes from the ANVISA directors’ meeting indicate the Implementation Plan deadline will shift to December 31, 2020. A new draft version of the Normative Instruction is expected to include phased-in deadlines by product category, beginning with controlled substances and antimicrobial medicines.
- November 8: The ANVISA directorate (DICOL) is formulating a new draft version of the Normative Instruction. Preliminary discussions at the November 4 DICOL meeting indicate that ANVISA may take a phased approach for in-scope products from 2022-2024. ANVISA proposed to move the Implementation Plan publication deadline to December 31, 2020.
- October 25: Due to changes in the membership of the ANVISA board of directors, ANVISA did not take up approval of final regulations/Normative Instruction on October 20. ANVISA did publish version 1.0 of the technical guidelines for connecting to the government reporting system, SNCM.
- October 11: The public discussions held on October 7 did not result in formal approval by ANVISA of the Normative Instructions due to a request by one ANVISA director to further study the drug set covered and possible economic impacts.
- September 27: The Brazilian Health Regulatory Agency (ANVISA) provided an update during last week’s SETRM conference that covered expectations for the December 1, 2020 compliance deadline and highlighted additional requirements for implementation and metadata reporting. ANVISA is expected to approve the Normative Instruction and Technical Guidelines on October 7, 2020.
- August 30: Brazil's SETRM seminar begins next week and will be kicked off with the latest announcements from The Brazilian Health Regulatory Agency (ANVISA) and other authorities on the current expectations for Brazil compliance.
- July 26: The Brazilian Health Regulatory Agency (ANVISA) confirmed that the Normative Instruction is done and is in legal review with the Brazilian Attorney General. ANVISA is targeting August for final publication.
- January 5: The Brazilian Health Regulatory Agency has extended the deadline for commentary on its Normative Instruction phased implementation deadlines. The new deadline is February 17, 2020.
- November 10: The Brazilian Health Regulatory Agency has approved a draft of regulations that lay out initial responsibilities for stakeholders in the country’s pharmaceutical supply chain. The document will soon be published for public commentary.
- April 7: The official pilot phase for serialization in Brazil will end in April 2019. At that time, the government will use learnings from the pilot program to create the final technical guidelines and will publish them in the next few months. The final implementation deadline of April 2022 will not shift, but the implementation timeline is now 24 months instead of 36 months and will begin in April 2020.
- February 24: ANVISA's extended pilot is planned to run in parallel with the eight month review and final regulation period. This timing means the 36 month implementation timeline would begin in April 2019 and end in April 2022 for all companies that have a requirement under the law and the products that are covered by the law.
- June 3: ANVISA reviewed timelines and the pilot will be extended until April 2019. Communication standards are being considered for both vertical government reporting and a potential use for horizontal peer to peer communications. A new version of communications guidelines has been published.
- April 8: Updated SNCM technical guidelines were circulated for law, which is currently in a pilot testing stage.
- March 11: ANVISA published the list of the pilot participants for the May through September pilot.
- January 14: Pilot execution and testing is now going to get underway in April/May when the central system is ready for integration and data management.
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